Medtronic Files 510(k) to Expand Hugo RAS into Hernia and Gynecologic Surgery
MDT•Medtronic submitted FDA 510(k) filings to extend its Hugo robotic-assisted surgery system into general (hernia repair) and gynecologic specialties, plus a 510(k) for its LigaSure RAS Maryland vessel-sealing instrument. It also received 510(k) clearance for ProGrip Advanced self-gripping polypropylene mesh used in robotic ventral hernia repair.
1. Expansion of Hugo RAS Indications
Medtronic has submitted FDA 510(k) filings to extend the Hugo robotic-assisted surgery system beyond urology into general surgery—including ventral hernia repair—and gynecologic procedures, aiming to broaden use at hospitals and ambulatory centers across the U.S.
2. LigaSure RAS Maryland Instrument Filing
The company filed a 510(k) for its LigaSure RAS Maryland vessel-sealing instrument, designed exclusively for the Hugo RAS system on the Valleylab FT10 energy platform, building on over 35 million procedures performed with LigaSure technology in more than 65 countries.
3. ProGrip Advanced Mesh Clearance
Medtronic received FDA 510(k) clearance for ProGrip Advanced self-gripping polypropylene mesh designed for robotic ventral hernia repair, which supports faster introduction through trocars and easier deployment compared to prior products, addressing roughly 470,000 annual U.S. hernia surgeries.
4. Commercial and Clinical Footprint
After FDA urologic clearance in December 2025, the Hugo RAS system is in commercial use at leading U.S. medical centers and has been applied in tens of thousands of procedures across over 35 countries, supported by hundreds of independently published scientific studies.
